The Recall Desk
ModerateFDA (Devices)·Z-0845-2021·Announced 2021-01-20

Ortho Clinical Diagnostics Recalls VITROS XT Chemistry Products ALB-TP Slides

Ortho Clinical Diagnostics is recalling VITROS XT Chemistry Products ALB-TP Slides due to potential interference from the drug eltrombopag.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. Since no specific injuries or illnesses are reported in the source text, and the issue is related to potential interference rather than a direct safety hazard like a defect or contamination, a score of 2 (Moderate) is appropriate.

Plain-English summary

Ortho Clinical Diagnostics Inc is recalling VITROS XT Chemistry Products ALB-TP Slides (Product Code 6844293). These in vitro diagnostic (IVD) products are used to quantitatively measure total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems. The recall affects all current, future, and past lots, with a total of 11,100 units distributed worldwide, including 9,802 in the United States and 1,298 in other countries.

The recall is being conducted due to potential interference from the drug eltrombopag. The source text does not specify the nature of the interference or report any specific patient injuries or illnesses. The ALB (Albumin) slides are not affected by this recall.

Healthcare facilities and laboratories using these slides should contact Ortho Clinical Diagnostics for further instructions on how to handle the affected products. Consumers are not directly affected as these are professional in vitro diagnostic devices.

The recalled product

Product
VITROS XT Chemistry Products ALB-TP Slides (ALB is not affected) - IVD quantitatively measures total protein (TP) concentration in serum and plasma using VITROS XT 3400 Chemistry Systems and VITROS XT 7600 Integrated Systems Product Code: 6844293
Manufacturer
Ortho Clinical Diagnostics Inc
Category
Medical Device — In Vitro Diagnostics
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • All Current
  • Future and Past Lots UDI: 10758750031771

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Ortho Clinical Diagnostics Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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